Virtual Reality Application During High Flow Nasal Oxygen Therapy in Children Effect on Anxiety Levels

NCT06886828 | Not Yet Recruiting

• 1 other identifier: UskudarU-SBE-TK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Determination of the effect of virtual reality goggles used during high-flow oxygen therapy on child anxiety in children

Conditions

Respiratory Distress

Keywords

high flow nasal oxygen therapy; virtual reality; Anxiety; distraction of attention; child

Outcome Measures

Primary Outcomes (1)

• Children's Emotional Manifestation Scale-CEMS

  It was developed in 2003 by William Li and Lopez to assess the level of anxiety in children aged 7-12 years. The Turkish validity and reliability of the scale was carried out by Yanık et al. in 2019 with the approval and opinion of William Li and Lopez on the appropriateness of evaluating anxiety in children aged 3-6 years. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 years during medical interventions. In the facial expression category, the facial expressions of the child are evaluated by the researcher. In the vocalisation category, tear status is evaluated. In the movement category, the child's body language is evaluated. In the interaction category, the child's verbal/non-verbal communication status is evaluated. In the cooperation category, the child's active / passive participation is evaluated. Each category is between 1-5 points and a total score between 5-25 points is obtained. Cronbach's Alpha value is 0.969.

  1 minute before the start of the procedure and 1 minute after 10 minutes of VR viewing

Secondary Outcomes (1)

• Wong and Baker Faces Pain Scale

  immediately before starting the process

Study Arms (2)

virtual reality

EXPERIMENTAL

Pre-Procedure: Information about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of the children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated ins

Device: Virtual reality goggles during HFNC

routine procedure

ACTIVE COMPARATOR

Information about the study will be given. Children with a pain score of '0' will be included in the groups. Verbal and written consent will be obtained from those who voluntarily agree to participate in the study. Video recording will be started with a mobile phone. Physiological parameters and anxiety level of children will be measured and recorded 1 minute before the treatment. HFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study.

Device: HFNC oxygen therapy with routine service application

Interventions

Virtual reality goggles during HFNC DEVICE

HFNC oxygen therapy will be started with video demonstration accompanied by virtual reality glasses. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the study, only the behaviours of the child during the procedure should be video recorded by a mobile phone. For the participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study. The study will continue until the 30-person intervention group is completed.

virtual reality

HFNC oxygen therapy with routine service application DEVICE

HFNC oxygen therapy will be started with routine ward practice. Physiological parameters and anxiety level will be recorded 10 minutes after HFNC oxygen treatment. Video recording will be terminated. Since the parameters in the scales should be evaluated by 2 nurses independent of the study during the research, only the behaviours of the child during the procedure should be video-recorded by means of a mobile phone. For participants and parents who want to participate in the study but do not approve the video recording, the parameters will be evaluated instantly by a researcher independent from the study

routine procedure

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is between 6-12 years old
• The child is receiving high flow nasal cannula oxygen therapy in the paediatric intensive care unit
• The child has no visual and hearing problems
• No pain according to the Wong-Baker pain scale
• No genetic, congenital, chronic or metabolic disease
• Being conscious and able to communicate verbally
• Written and verbal acceptance of the child and his/her parents to participate in the study after the information.

You may not qualify if:

• The child is in pain.
• The child is taking a sedative medication
• The child has a fever above 37°C
• The child presented with a severe asthma attack
• The child's saturation value was below 92% at the time of admission

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Şehit Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital

Istanbul, Sancaktepe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspnea; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Tuğba KARAKUŞ TÜRKER

  Üsküdar University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Tuğba KARAKAYA

CONTACT

+905435701207; tuggbbakarakaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups with traditional therapy control group.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)